NCT07879651Not yet recruiting
SPutum Induction and Nebuliser deviCEs for Patients With CF
SPICE-CF: Sputum Induction and Nebuliser Devices for Patients With Cystic Fibrosis - a Feasibility Trial
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
The goal of the SPICE-CF feasibility trial is to learn whether it is feasible to recruit and retain people with cystic fibrosis (CF) who are unable to produce sputum spontaneously in a study comparing two different nebuliser devices for sputum induction. The study will also assess how acceptable and practical the sputum induction procedures are. The main questions it aims to answer are: * Is it feasible to recruit and retain people with cystic fibrosis in a study comparing two nebuliser devices for sputum induction? * Can sputum be successfully obtained using each nebuliser device? * How acceptable are the two nebuliser devices to participants? * How long does sputum induction take with each device? * What microorganisms are identified in sputum collected using each device? * Can a visual scoring system be used to distinguish sputum from saliva and describe sputum characteristics? Researchers will compare a jet nebuliser with an E-flow Rapid nebuliser. Each participant will undergo sputum induction using both devices, with the order in which the devices are used determined at random. Participants will: * Attend two study visits, separated by at least 2 weeks * Receive a bronchodilator before sputum induction * Inhale hypertonic saline using either the jet nebuliser or E-flow Rapid nebuliser * Perform their usual airway clearance technique with supervision from a physiotherapist * Have their lung function, oxygen levels, heart rate, and chest sounds monitored * Provide sputum produced during the procedure for assessment and routine microbiological testing * Complete a brief questionnaire about their experience and the acceptability of each nebuliser device
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Diseases
- Cystic fibrosis
- NCT number
- NCT07879651
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Oct 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent eye surgery within past 6 weeks
Other illness
- History of intolerance to hypertonic saline 3% or 7%
- Lung function impairment (\<30%pp FEV1)
- Any known history or known family history of thoracic or cerebral aneurysm
Other
- Hypoxia (oxygen saturations of less than 90% on room air)
- Any haemoptysis within past 2 weeks
- Pneumothorax within 6 weeks
- Unstable cardiovascular status as determined by clinical assessment
- Acute pulmonary emboli (within 6 weeks)
- Acute undifferentiated chest pain
- Fractured ribs or other chest trauma in the past 6 weeks
- Inability to perform spirometry
- Treatment for a pulmonary exacerbation within 21 days of screening visit
- Inability to give consent
- Current participation in another interventional medicinal study
- Spontaneous sputum production
- Inability/unwillingness to expectorate
- Pregnancy or currently trying to conceive
Who the study is looking for
- Diagnosis of CF (confirmed by standard criteria)
- Sixteen years of age or over
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.